Download Single Unit and Unit Dose Packages of Drugs

144 Drug Distribution and Control: Distribution–Technical Assistance Bulletins
ASHP Technical Assistance Bulletin on
Single Unit and Unit Dose Packages of Drugs
Drug packages must fulfill four basic functions:
1. Identify their contents completely and precisely.
2. Protect their contents from deleterious environmental
effects (e.g., photodecomposition).
3. Protect their contents from deterioration due to handling (e.g., breakage and contamination).
4. Permit their contents to be used quickly, easily, and
safely.
Modern drug distribution systems use single unit packages to a great extent and, in fact, such packages are central
to the operation of unit dose systems, intravenous admixture
services, and other important aspects of pharmacy practice.
These guidelines have been prepared to assist pharmaceutical manufacturers and pharmacists in the development and
production of single unit and unit dose packages, the use of
which has been shown to have substantial benefits.
A single unit package is one that contains one discrete
pharmaceutical dosage form, i.e., one tablet, one 2-mL volume of liquid, one 2-g mass of ointment, etc. A unit dose
package is one that contains the particular dose of the drug
ordered for the patient. A single unit package is also a unit
dose or single dose package if it contains the particular dose
of the drug ordered for the patient. A unit dose package
could, for example, contain two tablets of a drug product.
General Considerations
Packaging Materials. Packaging materials (and the package
itself) must possess the physical characteristics required to
protect the contents from (as required) light, moisture, temperature, air, and handling. The material should not deteriorate during the shelf life of the contents. Packages should be
of lightweight, nonbulky materials that do not produce toxic
fumes when incinerated. Materials that may be recycled or
are biodegradable, or both, are to be preferred over those
that are not. Packaging materials should not absorb, adsorb,
or otherwise deleteriously affect their contents. Information
should be available to practitioners indicating the stability
and compatibility of drugs with various packaging materials.
Shape and Form. Packages should be constructed so that
they do not deteriorate with normal handling. They should
be easy to open and use, and their use should require little or
no special training or experience. Unless the package contains a drug to be added to a parenteral fluid or otherwise
used in compounding a finished dosage form, it should allow the contents to be administered directly to the patient (or
IPPB apparatus or fluid administration set) without any need
for repackaging into another container or device (except for
ampuls).
Label Copy. Current federal labeling requirements must be
adhered to, with attention also given to the items at right.
The desired copy and format are as follows:
Nonproprietary Name
(and proprietary name if to be shown)
Dosage Form (if special or other than oral)
Strength
Strength of Dose and Total Contents Delivered
(e.g., number of tablets and their total dose)
Special Notes (e.g., refrigerate)
Expiration Date
Control Number
1. Nonproprietary and proprietary names. The nonproprietary name and the strength should be the most
prominent part of the package label. It is not necessary to include the proprietary name, if any, on the
package. The name of the manufacturer or distributor
should appear on the package. In addition, the name of
the manufacturer of the finished dosage form should
be included in the product labeling. The style of type
should be chosen to provide maximum legibility, contrast, and permanence.
2. Dosage form. Special characteristics of the dosage
form should be a part of the label, e.g., extended release. Packages should be labeled as to the route of
administration if other than oral, e.g., topical use. In
a package containing an injection, the acceptable injectable route(s) of administration should be stated on
both outer and inner packages, i.e., both on the syringe
unit and carton (if any).
3. Strength. Strength should be stated in accordance with
terminology in the American Hospital Formulary
Service. The metric system should be used, with dosage
forms formulated to provide the rounded-off figures in
the USP table of approximate equivalents and expressed
in the smallest whole number. Micrograms should be
used through 999, then milligrams through 999, then
grams. Thus, 300 mg, not 5 gr, nor 325 mg, nor 0.3 g;
60 mg, not 1 gr, nor 0.06 g, nor 64.5 mg, nor 65 mg; 400
mcg, not 1/150 gr, nor 0.4 mg, nor 0.0004 g; mL (milliliters) should be used instead of cc (cubic centimeters).
4. Strength of dose and total contents delivered. The total
contents and total dose of the package should be indicated. Thus, a unit dose package containing a 600-mg
dose as two 300-mg tablets should be labeled “600 mg
(as two 300-mg tablets).” Likewise, a 500-mg dose of
a drug in a liquid containing 100 mg/mL should be
labeled “Delivers 500 mg (as 5 mL of 100 mg/mL).”
5. Special notes. Special notes such as conditions of storage (e.g., refrigerate), preparation (e.g., shake well or
moisten), and administration (e.g., not to be chewed)
that are not obvious from the dosage form designation
are to be included on the label.
6. Expiration date. The expiration date should be prominently visible on the package. If the contents must
be reconstituted prior to use, the shelf life of the final product should be indicated. Unless stability data
warrant otherwise, expiration dates should fall during
January and July to simplify recall procedures.
Drug Distribution and Control: Distribution–Technical Assistance Bulletins 145
7. Control number (lot number). The control number
should appear on the package.
Product Identification Codes. The use of product identification codes, appearing directly on the dosage form, is
encouraged.
Evidence of Entry. The package should be so designed that
it is evident, when the package is still intact, that it has never
been entered or opened.
Specific Considerations
Oral Solids
1. Blister package. A blister package should
a. Have an opaque and nonreflective backing (flat
upper surface of package) for printing.
b. Have a blister (dome or bubble) of a transparent
material that is, preferably, flat bottomed.
c. Be easily peelable.
d. If it contains a controlled substance, be numbered sequentially for accountability purposes.
2. Pouch package. A pouch package should
a. Have one side opaque and nonreflective for
printing.
b. Be easily deliverable, i.e., large tablets in large
pouches, small tablets in small pouches.
c. Tear from any point or from multiple locations.
d. If it contains a controlled substance, be numbered sequentially for accountability purposes.
3. The packages should be such that contents can be delivered directly to the patient’s mouth or hand.
Oral Liquids
1. The packages should be filled to deliver the labeled
contents. It is recognized that overfilling will be necessary, depending on the shape of the container, the
container material, and the formulation of the dosage
form.
2. The label should state the contents as follows: Delivers
____mg (or g or mcg) in ____mL.
3. If reconstitution is required, the amount of vehicle to
be added should be indicated. These directions may
take the form of “fill to mark on container” in lieu of
stating a specific volume.
4. Syringe-type containers for oral administration should
not accept a needle and should be labeled “For Oral
Use Only.”
5. Containers should be designed to permit administration of contents directly from the package.
Injectables
1. The device should be appropriately calibrated in milliliters and scaled from the tip to the fill line. Calibrated
space may be built into the device to permit addition
of other drugs. The label should state the contents as
follows: Delivers ____mg (or g or mcg) in ____mL.
2. An appropriate size needle may be an integral part
of the device. The needle sheath should not be the
plunger. The plunger should be mechanically stable in
the barrel of the syringe.
3. The device should be of such a design that it is patient
ready and assembly instructions are not necessary.
4. The sheath protecting the needle should be a nonpenetrable, preferably rigid material, to protect personnel from injury. The size of the needle should be
indicated.
5. The device should be of such a design that easy and
visible aspiration is possible. It should be as compact
as possible and of such a size that it can be easily
handled.
Parenteral Solutions and Additives
1. The approximate pH and osmolarity of parenteral
solutions should be stated on the label. The amount
of overfill also should be noted. Electrolyte solutions
should be labeled in both mEq (or millimole) and mg
concentrations. Solutions commonly labeled in terms
of percent concentration, e.g., dextrose, should also be
labeled in w/v terms.
2. Parenteral fluid container labels should be readable
when hanging and when upright or in the normal manipulative position.
3. Drugs to be mixed with parenteral infusion solutions
should be packaged into convenient sizes that minimize the need for solution transfers and other manipulations.
4. Partially filled piggyback-type containers should
a. Be recappable with a tamperproof closure.
b. Have a hanger.
c. Have volume markings.
d. Be designed to minimize the potential for contamination during use.
e. Contain a partial vacuum for ease of reconstitution.
5. If an administration set is included with the container,
it should be compatible with all large volume parenteral delivery systems.
Other Dosage Forms—Ophthalmics, Suppositories, Oint­
ments, etc. Dosage forms other than those specifically discussed above should be adequately labeled to indicate their
use and route of administration and should adhere to the
above and other required package labeling and design criteria.
Approved by the ASHP Board of Directors, November 14–15, 1984.
Revised by the ASHP Council on Clinical Affairs. Supersedes the
previous version, which was approved on March 31–April 1, 1977.
Copyright © 1985, American Society of Hospital Pharmacists, Inc.
All rights reserved.
The bibliographic citation for this document is as follows: American
Society of Hospital Pharmacists. ASHP technical assistance bulletin
on single unit and unit dose packages of drugs. Am J Hosp Pharm.
1985; 42:378–9.